Women

1

• Womens Health and the Media
• Where do we find trustworthy information?

2

• What are the key challenges?
• Media portrayals of new medical research often
  inaccurate
• A societal embracing of the quick fix or pill
  for every ill approach

3

• Key Challenges.
• Increasing influence of the pharmaceutical
  industry over physician prescribing practices as
  well as the educational and advertising materials
  aimed at the consumer or patient

4

• Amidst the plethora of websites, ads and other
  sources, how does one find trustworthy
  information?

5

• Know the source of your information and look out
  for conflicts of interest
• Utilize non-commercial websites prepared by those
  who know how to evaluate the quality of the
  research that they cite
• Use more than one source

6

• EXAMPLE OF CHILDBIRTH AND THE RISING CESAREAN
  SECTION RATES IN THE UNITED STATES

7
Reasons for Rising Cesarean Rates(IOM 1989
report)

• 30 of the rise due to diagnosis of dystocia
  (abnormal or difficult labor)
• 25-30 due to repeat cesarean section
• 10-25 due to breech presentation
• 10-15 due to fetal distress

8
Current reasons for rising cesarean rates

• Primarily changes in obstetrical practice, such
  as
• - More repeat cesareans
• - More refusals to allow VBACs
• - Concerns about malpractice
• - More advocates of medically- unnecessary
  cesareans

9

• NCHS TRACKING IN 2004
• Cesarean delivery rate rose 6 percent in 2004 to
  29.1 percent of all births, the highest rate ever
  reported in the United States
• From http//www.cdc.gov/nchs/products/pubs/pubd/h
  estats/prelimbirths04/prelimbirths04health.htm

10
TRACKING in 2004 (cont.)The rate has
increased by over 40 percent since 1996. For
200304 the primary cesarean rate rose 8 percent,
and the rate of vaginal birth after cesarean
delivery (VBAC) dropped 13 percent. The primary
rate has climbed 41 percent and the VBAC rate has
fallen 67 percent since 1996.
11
NIH Meetingon Cesareans by Maternal Request
(March 27-29, 2006)Will media coverage of this
meeting and its report result in more cesareans
with no medical indication (elective surgery)?
12

• QUESTIONS ADDRESSED AT THE NIH MEETING
• What is the trend and incidence of cesarean
  delivery in the US and other countries?
• What are the benefits and harms of cesarean by
  request vs. attempted vaginal birth (both
  short-term and long-term)?
  (Cont.)

13
QUESTIONS (cont.)

• What factors influence benefits and harms?
• What research should be done to get better
  evidence for making decisions regarding cesarean
  delivery on request vs. attempted vaginal
  delivery?

14
Panels RecommendationsFinal report at
www.consensus.nih.gov/2006

• Insufficient evidence, so more research needed on
  benefits and risks of cesarean delivery on
  maternal request vs. planned vaginal delivery
• Until better evidence is available, any decision
  to do cesareans upon maternal request should be
  carefully considered

15
Recommendations (cont.)

• Not recommended for women desiring several
  children given rising risks of placenta previa
  and accreta with each cesarean delivery
• No cesareans upon maternal request prior to 39
  weeks or without verification of lung maturity
  (because of significant risks of neonatal
  respiratory complications)

16
Recommendations (cont.)

• Effective pain management services should be
  available for all women so that fear of pain is
  not a motivating factor for an elective cesarean
• NIH (or other appropriate Federal agency)
  establish a website with up-to-date information

17

• The final report did not adequately consider
  many recognized long-term adverse outcomes
  associated with cesarean surgery and did not take
  into account the impact that avoidable obstetric
  practices can cause during vaginal birth.

18

• From the national Listening to Mothers II Survey
  of the Childbirth Connection in NYC
  (http//www.childbirthconnection.org/article.asp?c
  k10401)
• 56 of women who wanted a vaginal birth after
  having had a cesarean said a doctor denied them
  that option.
• 1 out of every 4 women polled who had caesarean
  said they felt pushed into having the surgery.

19
Excellent discussions of this meeting

• Diony Youngs editorial in the September 2006
  issue of BIRTH Cesarean Delivery on Maternal
  Request Was the NIH Conference Based on a
  Faulty Premise?
• Henci Goers piece in Lamaze e-news (June 2006)
• Rona McCandlishs article in MIDWIFERY (v.22,
  2006) Meeting maternal request for Cesarean
  section paving the road to hell?

20
Possible consequences of these Recommendations

• An increasing trend towards considering cesarean
  birth as a normal birth with benefits/harms on
  par with vaginal birth
• Misleading coverage in the media
• Continued distortion of the concept of womens
  right to choose

21

• Maternal mortality and severe morbidity
  associated with low-risk planned cesarean
  delivery versus planned vaginal delivery at term
• Liu et al. CMAJ Feb 2007
• (This study used a breech group as a surrogate
  for an elective cesarean group)

22

• Among healthy women in the study
• 27.3 per 1,000 women in the planned cesarean
  group (breech births) had severe complications
  (such as major infections or blood clots) vs. 9
  per 1,000 women in the planned vaginal group

23

• From the CMAJ commentary
• This study provides additional support to a
  growing body of evidence suggesting that primary
  elective cesarean birth may place both mother and
  newborn at greater risk for adverse outcomes than
  planned vaginal birth

24

• COSMETIC SURGERY is the fastest growing medical
  specialty in the U.S.

25

• Breast implants solely for cosmetic purposes
  are increasing in popularity despite substantial
  risks associated with both silicone and saline
  implants.

26

• See the booklet prepared by the US Food and Drug
  Administration for photographs and descriptions
  of adverse implant outcomes such as
  disfigurement, capsular contracture (when the
  breast becomes hard and misshapen), and
  deflation
• www.fda.gov/cdrh/breastimplants)

27
Sample Photo from Implant Makers Website
28
Photo of Capsular ContractureFrom FDA Booklet
29
This is the same 27-year old woman after her
painful implants were removed
30
Necrosis in mastectomy patient with implants for
one week
31
After removal of one womans leaking silicone
implants
32

• According to the American Society for Aesthetic
  Plastic Surgery, 364,610 women got breast
  implants in 2005. The number was up 9 percent
  from 2004.

33

• It's like being set free, from being trapped in
  a bad body, to being set free in a nice body.
• From More women having mommy makeovers by
  Kim BaerThe Free Lance-Star
• (Fredericksburg, VA) March 13, 2007

34

• A survey by the American Society of Plastic
  Surgeons showed that nearly 40 percent of plastic
  surgery patients believe they should have been
  more proactive in learning about potential side
  effects and complications before surgery.

35
There are over-the counter creams and lotions.
And then theres Botox Cosmetic. My doctor says
theyre just not the same. She said only
prescription Botox is approved by the FDA to
treat the frown lines between your brows
36

• A large coalition of groups
• See www.safecosmetics.org
• Skin Deep a report of the Environmental
  Working Group, helps consumers and workers to
  better protect themselves from known or suspected
  carcinogens and reproductive toxins.

37
In October 2005, Governor Schwarzenegger signed
the Safe Cosmetics Act into California law. As of
January 1, 2007, cosmetics manufacturers in the
state will be required to disclose any product
ingredients that cause cancer or birth defects. 
38
Harmful Substances to Avoid

• Para-phenylenediamine, a chemical found in some
  dark hair dyes (may increase risk for bladder
  cancer in humans)
• Phthalates, typically used as a solvent and
  plastic softener and also found in many shampoos
  and other hair products, cosmetics, deodorants
  and nail polish (has been linked to cancer and to
  birth defects of the male reproductive system).
  To learn more, go to www.nottoopretty.org.

39

• To avoid (continued)
• Talc, in talcum powder (has been linked to a 60
  increase in the risk for ovarian cancer in women
  who use it in the genital area).
• Propylene glycol, an ingredient found in some
  moisturizing products and skin creams (may damage
  the kidneys and liver).

40
What to do to minimize risk

• Read labels carefully and choose all-natural
  alternatives, such as products made with olive
  oil, safflower oil or oatmeal, whenever possible.
  

41

• Direct-to-Consumer Advertising of Prescription
  Drugs
• Misleading Ads and How They Hurt Us

42
The Public Gets Misinformation

• Benefits are often overstated, while risks are
  understated
• FDA warning letters are issued after the ads run
• Corrective ads are rarely required
• Withdrawal of an ad is the only penalty

43

• Ads are geared primarily to selling more drug
  product, not educating the user
• The ads work the most highly advertised drugs,
  accompanied by promotional campaigns geared to
  physicians, sell extremely well

44

• Top selling drug in the world?

45

• Lipitor (Pfizer)
• (with more than 13 billion dollars in sales in
  2005)

46

• Drugs can be quite useful, but Pills for
  Prevention may not be the best approach.

47

• Important to promote a view of public health
  that stresses primary prevention identifying
  and eliminating disease-causing agents in our
  food, water, and air.

48

• Precautionary Principle of Public Health
• When an activity raises threats of harm to the
  environment or human health, precautionary
  measures should be taken even if some cause and
  effect relationships are not fully established.
• Science and Environmental Health Network
  www.sehn.org

49

• Consider the example of an ad for SARAFEM
  (Prozac repackaged as a pink and purple capsule)
  at www.sarafem.com
• (ad since removed)
•  

50

• Think its PMS? Think Againit could be PMDD
• Picture of a young woman trying to zip her
  jeans (too bloated?) picture of another woman
  seemingly distressed
• Then text follows

51

• Irritability, sadness, sudden mood changes,
  tension, bloating. If you suffer from many of
  these symptoms month after month and they clearly
  interfere with your daily activities and
  relationships you could have PMDD

52

• PMDD, Premenstrual Dysphoric Disorder, is a
  distinct medical condition that is characterized
  by intense mood and physical symptoms right
  before your period.

53
Sarafem can help. Doctors can treat PMDD with
medication for PMDD

• Constantly flashing, each shown consecutively
• Mood swings---irritability---bloated feeling

54

• Drug regulators in Europe forced Eli Lilly to
  drop PMDD as one of the approved uses for Prozac
  (Sarafem), as the data did not provide adequate
  evidence of efficacy.

55

• Current content at this website has changed.
  Sample quote
• Many physicians believe that Sarafem helps to
  correct the imbalance of serotonin that could
  contribute to PMDD.

56

• Antidepressants increased the risk of suicidal
  thinking and behavior in children and teenagers
  with depression and other psychiatric disorders.
• Patients starting therapy should be observed
  closely for worsening depression symptoms,
  suicidal thoughts or behavior, or unusual changes
  in behavior.
• Sarafem is not approved for use in patients
  under the age of 18.

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58

• The ad was misleading because it mixed
  relative risk with absolute risk, noting, for
  example, the following
• 44 fewer breast cancers in women taking
  tamoxifen vs. women taking a placebo
• But there was NO mention of the following
  relative risk a 252 increased risk of
  endometrial cancer

59

• The ad also noted a risk of serious problems
  such as endometrial cancer or blood clots at
  only 1-2 (absolute risk)
• But left out was any mention that women have
  only a 1.8 chance of benefiting from the drug
  (absolute benefit)

60

• Unpaid advertising also a problem
• Parade magazine, for example, put model Lauren
  Hutton on its cover for a piece on celebrity
  beauty tips, and quoted her saying her "No. 1
  secret is estrogen. Its good for your moods,
  its good for your skin. If I had to choose
  between all my creams and makeup for feeling and
  looking good, Id take the estrogen.

61

• The article didnt mention that Hutton was a
  paid spokesperson for Wyeth Ayerst, and that she
  appeared in their ads. It also didnt mention
  that Hutton's claims for estrogen's benefits were
  not backed up by valid scientific evidence.

62

• Female Sexual Dysfunction
• Is this a serious problem requiring primarily
  biomedical solutions, or is a different approach
  most often called for?

63
In 1999, Pfizer consultants analyzed one question
from a 1994 survey and produced an overly
simplistic conclusion that 43 of American
women suffer from sexual dysfunction
64

• Idea Marketing
• A disease awareness campaign is now building a
  drug market usingthe 43 FSD statistic.
• (Slide Courtesy of Leonore Tiefer)

65
To promote The Hunt for the
Pink Viagra(Slide Courtesy of Leonore
Tiefer)
66

• For more information about female sexual
  problems, see the website of the Campaign for a
  New View of Womens Sexual Problems
• www.fsd-alert.org

67
Menopause
Every day 5,000 women in the U.S. enter
menopause, the so-called change of life
68
What do we think about menopause?

• Some women see it as the end of sex or the end
  of youth
• Some see a passport to freedom (no fear of
  getting pregnant, no messing with pads and
  tampons, no more shoulds about how one needs to
  look)
• Possibly more time for oneself

69
What influences our thinking?

• Media messages that worship youth, thinness, and
  suggest its not OK to grow old
• Conversations with other women about their actual
  experiences with menoapuse

70
Opportunities for Medicalization

• Less/no interest in sex
• Hot flashes/vaginal dryness and loss of
  elasticity
• Loss of bone density

71

• More spreading waistlines and sagging skin
• Memory problems
• Depression
• Problems with sleep

72

• Approaches to dealing with sleep problems other
  than prescription sleeping drugs such as Ambien
  and Lunesta
• Yoga/exercise
• Avoiding caffeine
• Deep breathing/massage at bedtime from a partner
• Sleep in a cool room

73
Non-hormonal approaches to dealing with hot
flashes

• Wear layered clothing
• Use fans
• Put palms or bare feet on a cold surface
• Cold pack under the pillow
• Exercise, yoga, deep breathing
• Less caffeine, less spicy foods, less alcohol
  (especially red wine)

74
Removing health ovaries

• US federal data from the late 1990s
• 78 of women 45-64 who have had a hysterectomy
  also had healthy ovaries removed (even though
  most were not at particular risk of developing
  ovarian cancer).

75

• Latest research shows that for women without a
  family history of ovarian cancer there is a
  significant reduction in death from heart disease
  and complications of osteoporosis IF THE OVARIES
  ARE KEPT, especially until the age of 65.

76

• KEY FINDINGS OF WILLIAM PARKER et al study in
  2005
• For 10,000 women 50-54 yrs old who undergo a
  hysterectomy with oophorectomy, there will be 47
  fewer cases of ovarian cancer by the time these
  women reach 80 when compared with a similar group
  who keep their ovaries.

77

• BUT the oophorectomy group will suffer 838
  additional deaths from coronary heart disease as
  well as 158 more deaths from hip fractures.
  (Numbers reflect women who do NOT have estrogen
  therapy there is a smaller survival benefit to
  keeping the ovaries in women taking estrogen.)

78

• Ads for bone density screening now pitched at
  women around 50 yrs of age
• Creation of the T score and a new
  classification called osteopenia (for -1 to -2.5
  scores)
• Merck stopped by the FDA from using the claim
  menopause is the single most important cause of
  osteoporosis in their ads

79
Cloning, Stem Cells and Inheritable Genetic
ModificationSpecial case of embryo cloning
(somatic cell nuclear transfer)
80
Research the promises and the challenges

• Balancing our interest in developing new medical
  therapies with the need to protect research
  subjects and the need to preserve values of
  social justice and equity
• Developing technologies that will be accessible
  to most

81

• Often Ignored Concerns
• Risks to womens health
• Gateway to designer babies
• Unethical experimentation on humans
• Fueling of a new eugenics movement

82
Risks to Womens Health from Research Cloning

• Also known as therapeutic cloning or somatic
  cell nuclear transfer (SCNT), SCNT requires the
  collection of many eggs from women willing to
  undergo egg extraction procedures.

83
Some Concerns about Multiple Egg Extraction

• Use of leuprolide acetate (Lupron), a GnRH
  agonist, to shut down the ovaries, is not
  FDA-aproved for this purpose (Antagon, a GnRH
  antagonist that is also used, is approved for
  this use.)
• Use of drugs that hyper-stimulate the ovaries to
  produce multiple follicles

84

• As Spring of 1999, US Food and Drug
  Administration (FDA) had received 4228 reports of
  adverse drug events from women using Lupron.
  325 of the adverse events for women reported to
  the FDA resulted in hospitalization, and
  additionally, 25 deaths were reported.

85
The Research Cloning Debate

• The most vocal participants have been
• Anti-choice conservatives opposed to the
  destruction of embryos, who favor a permanent ban
• Biomedical researchers and their allies, who are
  wary of or opposed to regulatory oversight

86
Good Resources

• National Womens Health Network (DC)
• Breast Cancer Action (SF)
• Collaborative on Health and the Environment
• Science and Environmental Health Network
• Silent Spring Institute (Newton, MA)
• Teen Voices magazine (Boston)
• Center for Medical Consumers (NYC)
• Canadian Womens Health Network (CWHN)
• www.ourbodiesourselves.org

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88

• www.ourbodiesourselves.org
• May 2005

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